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Phase 2 N=30 Treatment

The EndoBARR Trial (Endometrial Bevacizumab, Atezolizumab, Rucaparib)

Endometrial Cancer · Uterine Carcinosarcoma

Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Treatment Related Overall Response Rate — 30 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Rucaparib (Drug); Bevacizumab (Drug); Atezolizumab (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Medical College of Wisconsin
Primary completion
Mar 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Treatment Related Overall Response Rate
30
PRIMARY
To Estimate the Overall Response Rate (ORR) of Patients With Progressive/Persistent or Recurrent Endometrial Cancer on Study-directed Therapy, Using the Combination of Rucaparib, Bevacizumab and Atezolizumab.
30
SECONDARY
Progression Free Survival
SECONDARY
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE V5.0
SECONDARY
Overall Survival

Summary

To demonstrate the efficacy and safety of the combination of rucaparib, bevacizumab and atezolizumab in recurrent, progressive endometrial carcinoma.

Eligibility Criteria

Inclusion Criteria

  • Patients must have recurrent or persistent/progressive endometrial carcinoma, which is refractory to curative therapy or established treatments. Histologic confirmation of the original primary tumor is required. Stained slides of either the primary or recurrent tumor are required. If primary FFPE samples are not available, a biopsy demonstrating recurrent disease must be obtained. Pathologic Slides/Blocks will be reviewed at the primary site for confirmation.
  • Patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, transitional cell carcinoma and uterine carcinosarcoma (MMT).
  • Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma. Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a chemotherapy regimen. Patients may have had, but are not required to have received, a second chemotherapeutic regimen for recurrent disease.
  • All patients must have measurable disease, as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each target lesion must be ≥ 10 mm when measured by

CT or MRI. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI.

  • Patients may be enrolled if they do not have a target lesion (>= 10 mm lesion or >=15 mm lymph node), if they have measurable disease. This is defined by RECIST 1.1 as a suspicious lesion =10mm but 2+, 24-hour urine protein must be obtained and should be 1.5 X institutional ULN Hepatic Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR

≤ 5 X ULN for subjects with liver metastases Albumin >2.5 mg/dL Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT)

Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants aCreatinine clearance should be calculated per institutional standard.

4.2 Exclusion Criteria

  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of the other malignancy being present within the last two years. Patients with Ductal Carcinoma in situ (DCIS) of the breast in the prior two years may be enrolled on study if the treatment required no chemotherapy or radiation. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
  • Patients must not have had exposure to Bevacizumab, PARPi, or immunotherapy. Patients may have had exposure to anti-angiogentic therapy provided it was not Bevacizumab.
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer within the last three years are excluded. Prior radiation for localized cancer of the breast, head and neck or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of endometrial cancer within the last three years are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than two years prior to registration, and that the patient re
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03694262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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